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Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Overall Recruitment Status: Enrollment not started
Official Title
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Region Sponsors
NRG Oncology
Acronym KP IRB No.
Study Type Phase
Clinical Trial Phase III
Study Population Description
(Adult, Older Adult) Male and Female with histologically/pathologically confirmed Stage IIIA or Stage IIIB colon adenocarcinoma (T1-3, N1/N1c) with R0 resection
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Detailed Description
Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.
Gender Age Limit
Male & Female 18 years & older
Inclusion Criteria
  • The patient must have an ECOG performance status of 0 or 1
  • Patients must have histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria. NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B
  • No radiographic evidence of overt metastatic disease within 28 days prior to study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis)
  • The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation)
  • The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible
  • The resected tumor specimen and a blood specimen from patients with Stage IIIA or Stage IIIB colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera
  • Please contact study team for additional inclusion criteria
Exclusion Criteria
  • Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.)
  • Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected
  • Tumor-related bowel perforation
  • History of prior invasive colon malignancy, regardless of disease-free interval
  • History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary
  • Please contact study team for additional exclusion criteria

Keywords and/or Specific Medical Conditions
  • 5-Fluorouracil (5-FU)
  • Adjuvant Chemotherapy
  • mFOLFOX6
  • Capecitabine
  • Natera
  • Oxaliplatin
  • ctDNA negative
  • Signatera
  • ctDNA positive
  • Stage II
  • Irinotecan
  • Stage III
  • Leucovorin
  • Oncology (Adult)
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Alexander Menter, MD
Contact Information:
- Ivana Marchlewicz, MPH
-Lone Tree Medical Offices - Lone Tree

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